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Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469168
Recruitment Status : Terminated (lack of funding)
First Posted : June 11, 2015
Results First Posted : April 3, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Leon Nesti, Walter Reed National Military Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Wounds and Injury
Interventions Device: Recell
Procedure: Control
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ReCell Control
Hide Arm/Group Description

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix

Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Trial closed             1             0
Arm/Group Title ReCell Control Total
Hide Arm/Group Description

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix

Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
did not enroll any additional participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 1 participants
29  (0) 29  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Number of Participants With Adverse Event
Hide Description Number of patients with a treatment-related adverse events requiring surgical intervention prior to Week 12 post-treatment and all serious adverse event (SAE) occurrences throughout the study
Time Frame Prior to or at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
did not enroll any additional participants
Arm/Group Title ReCell Control
Hide Arm/Group Description:

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix

Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
0
2.Secondary Outcome
Title Number of Participants With Confirmed Treatment Area Closure
Hide Description Complete wound closure is defined as skin wound re-epithelialization at 95% or greater at treated wound site and donor sites confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.
Time Frame Prior to or at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
did not enroll any additional participants
Arm/Group Title ReCell Control
Hide Arm/Group Description:

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix

Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
0
Time Frame 6 weeks and 24 weeks post-operation
Adverse Event Reporting Description Do not differ from clinicaltrials.gov definitions.
 
Arm/Group Title ReCell Control
Hide Arm/Group Description

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix

Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix

All-Cause Mortality
ReCell Control
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)      0/0    
Hide Serious Adverse Events
ReCell Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/0    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ReCell Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
Surgical and medical procedures     
Graft Sloughing   1/1 (100.00%)  1 0/0  0
Malodorous wound   1/1 (100.00%)  1 0/0  0
Exudate around graft   1/1 (100.00%)  1 0/0  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jody Richardson, MSN, RN
Organization: Walter Reed National Military Medical Center
Phone: 301-295-7798
EMail: jody.richardson.ctr@usuhs.edu
Layout table for additonal information
Responsible Party: Leon Nesti, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT02469168    
Other Study ID Numbers: WRNNMC 391911-5
First Submitted: June 3, 2015
First Posted: June 11, 2015
Results First Submitted: March 9, 2018
Results First Posted: April 3, 2018
Last Update Posted: August 7, 2018